Integra LifeSciences Corp. (NeuroSciences): CODMAN Disposable Perforator 11mm. Cranial Perforator.
Read the official notice at FDA (device) →
Get alerts for Integra LifeSciences
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Integra LifeSciences Corp. (NeuroSciences)
- Product
- CODMAN Disposable Perforator 11mm. Cranial Perforator.
- Reason / hazard
- Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czechia, Ecuador, France, French Guiana, Germany, Greece, India, Ireland, Italy, Japan, Jordan, Korea, Lithuania, Mexico, Morrocco, Netherlands, New Zealand, Palestine, State of, Philippines, Portugal, Puerto Rico, Qatar, Republic of North Macedonia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan , Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Vietnam.
- Recall initiated
- 2025-09-26
- Code info
- Model No. 261222; UDI: 10381780513612; Lot No. 7221964, 7221972, 7221976, 7221977, 7221978, 7221979, 7221980, 7221981, 7221982, 7221983, 7221984, 7221985, 7221986, 7221987, 7221988, 7221989, 7221990, 7221991, 7230624, 7230625, 7230626, 7230627, 7230628, 7230629, 7230630, 7230631, 7230632, 7230633, 7230634, 7230635, 7230636, 7230637, 7230638, 7230639, 7230640, 7230641, 7230642, 7230643, 7230644, 7230645, 7230646, 7230647, 7230648, 7230649, 7230650, 7230651, 7230652, 7230653, 7230654, 7230655, 7230656, 7230657, 7230658, 7230659, 7230660, 7230661, 7282989, 7282990, 7282991, 7282992, 7282993, 7282994, 7282995, 7282996, 7282997, 7282998, 7282999, 7283000, 7283001, 7283002, 7283003, 7283004, 7283005, 7283006, 7283007, 7293432, 7293433, 7293434, 7293435, 7293436, 7293437, 7293438, 7293439, 7293440, 7293441, 7293442, 7293443, 7293444, 7293445, 7293446, 7293447, 7293448, 7293450, 7308709, 7308710, 7293449, 7293451, 7308706, 7308707, 7308708, 7308711, 7308712, 7308713, 7308714, 7308715, 7322887, 7322888, 7322889, 7322890, 7322891, 7323305, 7323306, 7323307, 7323308, 7323309, 7332669, 7332670, 7332671, 7332672, 7332673, 7332674, 7332675, 7332676, 7332677, 7348757, 7348758, 7348759, 7348760, 7348761, 7348762, 7348763, 7348764, 7348765, 7348766, 7348767, 7348768, 7348769, 7348770, 7348771, 7348772, 7348773, 7348774, 7348775, 7348776, 7348777, 7348778, 7348779, 7348780, 7348781, 7348782, 7371090, 7371091, 7371092, 7371093, 7371094, 7371095, 7371096, 7371097, 7371098, 7371099, 7371100, 7371101, 7371102, 7371103, 7387974, 7387975, 7387976, 7387977, 7387978, 7387979, 7387980, 7387981, 7387982, 7387983, 7387984, 7387985, 7387986, 7387987, 7387991, 7402327, 7402328, 7402329, 7402330, 7402331, 7402332, 7402333, 7402334, 7406854, 7406855, 7406856, 7406857, 7406858, 7406859, 7406860, 7406861, 7448431, 7448432, 7448433, 7448434; Expiration Date: 2028-04-30 to 2029-07-31.
- Product quantity
- 16,251 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Princeton
- State
- NJ
- Country
- United States
- Event id
- 97623
Free daily digest + "My products" watchlist